Cardiovascular, cancer account for most clinical trial deaths

During the current year, 211 deaths were reported, Health and Family Welfare Minister Ghulam Nabi Azad today told Lok Sabha in a written reply.

Of the 211 deaths, 82 were in cardiovascular and 66 in cancer categories, while five were cerebrovascular deaths, 12 anti-diabetic and eight antiviral/anti-fungal category deaths. As many as 38 deaths were due to other reasons, he said.

Azad said the number of clinical trial deaths reported in 2010, 2011 and up to June 2012 were 668, 438 and 211 respectively.

During anti-cancer clinical trials, 226 deaths took place in 2010 and 139 in 2011, while there were 66 deaths this year till June.

Similarly, during clinical trials in Cardiovascular category, 368 deaths took place in 2010, in 2011 it was 229 and 82 in 2012 till June.

Listing out steps taken to bring in transparency in the system of approving new drugs, Azad said registration of all clinical trials with Indian Council of Medical Research (ICMR) has been made mandatory since June 2009.

He said 12 new Drug Advisory Committees and six Medical Device Advisory Committees have been set up by the government. Besides, a general experts pool for medical device advisory committees has also been set up.

Azad said every approval for conducting clinical trials now includes a condition that in case of study related injury or death, applicant will provide complete medical care as well as compensation and statement to this effect should be incorporated in the consent form.